FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with CEPROTIN, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti kollha irrapportati b'CEPROTIN, ara l-Fuljett tal-Pakkett.
English: It contains the active substance human protein C.
Maltese: Huwa fih is-sustanza attiva proteina Ċ tal-bniedem.
English: CEPROTINCEPROTINOther information about CEPROTIN:
Maltese: Tagħrif ieħor dwar CEPROTIN:
English: What is the risk associated with CEPROTIN?
Maltese: X'inhu r-riskju assoċjat ma' CEPROTIN?
English: CEPROTIN is a powder and solvent, which are mixed together to form a solution for injection.
Maltese: CEPROTIN huwa trab u solvent, li jitħalltu flimkien biex jifformaw soluzzjoni għal injezzjoni.
English: The Committee for Medicinal products for Human Use (CHMP) decided that CEPROTIN's benefits are greater than its risks for patients with severe congenital protein C deficiency.
Maltese: Il-Kumitat għal Prodotti Mediċinali għal Użu tal-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' CEPROTIN huma akbar mir-riskji tiegħu għal pazjenti b'defiċjenza konġenitali ta' proteina Ċ severa.
English: CEPROTIN treatment should only be started by a doctor who has experience in this type of therapy and where it is possible to measure protein C activity.
Maltese: Kura b'CEPROTIN għandha tinbeda minn tabib li għandu esperjenza f'din it-tip ta' terapija u fejn huwa possibbli li tkejjel l-attività ta' proteina Ċ.
English: An injection of CEPROTIN gives an immediate but temporary increase in levels of protein C. Replacement of protein C in protein C deficient patients should control or prevent thrombotic (clotting) problems in these patients.
Maltese: Injezzjoni ta' CEPROTIN tagħti żieda immedjata iżda temporanja fil-livelli ta' proteina Ċ.
English: 1 tube
Maltese: 1 tubu
English: Extraction solvent: n-Heptane
Maltese: Solvent tal-estratt: n-Heptane
English: Gel
Maltese: Ġell
English: as well as hybrids of both species (equivalent to 0.5 - 1.0 g birch bark), corresponding to 72-88 mg betulin.
Maltese: --1 1g ta' ġell fiha: 100 mg ta' estratt (bħala estratt niexef, raffinat) mill-qoxra tal-betula minn Betula pendula Roth, Betula pubescens Ehrh. kif ukoll minn ibridi taż-żewġ speċi (ekwivalenti għal 0.5-1.0 g ta' qoxra tal-betula), li jikkorrespondu għal 72-88 mg betulin.
English: Cutaneous use Tube (alu)
Maltese: Użu taħt il-ġilda Tubu (alu)
English: 1g of gel contains: 100 mg extract (as dry extract) from birch bark from Betula pendula Roth, Betula pubescens Ehrh.
Maltese: Numru MA (UE) Isem (ivvintat) Qawwa Għamla Farmaċewtika
English: Pack size
Maltese: Imballaġġ Primarju
English: EMA/244278/2019 EMEA/H/C/004883
Maltese: EMA/244278/2019 EMA/H/C/004883
English: Further information on Esperoct can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/esperoct.
Maltese: ema.europa.eu/medicines/human/EPAR/esperoct.
English: Other information about Esperoct
Maltese: Informazzjoni oħra dwar Esperoct
English: These include swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest, tingling and wheezing.
Maltese: Dawn jinkludu nefħa, ħruq u tingiż fis-sit tal-injezzjoni, tertir, fwawar, raxx bilħakk, uġigħ ta' ras, ħorriqija, pressjoni tad-demm baxxa, letarġija, dardir u rimettar, nuqqas ta' sabar, taħbit tal-qalb mgħaġġel, għafis tas-sider, tagħrix u tħarħir ta' nifs.
English: Esperoct contains the active substance turoctocog alfa pegol.
Maltese: Esperoct fih is-sustanza attiva turoctocog alfa pegol.
English: In a study involving patients between 12 and 66 years of age, 175 patients given Esperoct every 4 days or twice weekly as preventive treatment had, on average, around 4 bleeding episodes a year, achieving the target of the study, which was less than 8.5 episodes a year.
Maltese: Fi studju li involva pazjenti li għandhom bejn it-12-il sena u s-66 sena, 175 pazjent li ngħataw Esperoct kull 4 ijiem jew darbtejn fil-ġimgħa bħala kura preventiva, kellhom bħala medja 4 episodji ta' emorraġija fis-sena, u b'hekk inkisbet il-mira tal-istudju, li kienet inqas minn 8.5 episodji fis-sena.
English: What are the risks associated with Esperoct?
Maltese: X'inhuma r-riskji assoċjati ma' Esperoct?
English: In a second study in 68 children aged below 12 years, Esperoct given as preventive treatment reduced the number of bleeding episodes to around 2 episodes a year.
Maltese: Fit-tieni studju fuq 68 tifel u tifla taħt it-12-il sena, Esperoct li ngħata bħala kura preventiva, naqqas in-numru ta' episodji ta' emorraġija għal madwar 2 episodji fis-sena.
English: Esperoct is given as an injection into a vein.
Maltese: Esperoct jingħata bħala injezzjoni ġol-vina.
English: Hypersensitivity (allergic) reactions can occur with Esperoct and are uncommon (affecting up to 1 in 100 people).
Maltese: Reazzjonijiet ta' ipersensittività (allerġiċi) jistgħu jseħħu b'Esperoct u mhumiex komuni (jaffettwaw sa persuna 1 f'kull 100).
English: Esperoct has been shown to be effective at preventing and treating bleeding episodes in patients with severe haemophilia who were previously treated with other factor VIII products.
Maltese: Esperoct intwera li huwa effettiv fil-prevenzjoni u fil-kura ta' episodji ta' emorraġija f'pazjenti b'emofilja severa li fil-passat ikunu ġew ikkurati bi prodotti oħra tal-fattur VIII.
English: These patients had on average around 32 bleeding episodes a year and Esperoct was successful at stopping the bleeds 97% of the time after 1 or 2 injections.
Maltese: Dawn il-pazjenti kellhom medja ta' madwar 32 episodju ta' emorraġija fis-sena u Esperoct irnexxielu jwaqqaf il-fsadi f'97 % tal-każijiet wara injezzjoni 1 jew 2 injezzjonijiet.
English: The company that markets Esperoct will carry out a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues and organs.
Maltese: Il-kumpanija li tqiegħed Esperoct fis-suq ser twettaq studju biex jiġu investigati l-effetti potenzjali talakkumulazzjoni ta' PEG fil-korojde pleksus tal-moħħ u f'organi oħra.
English: The active substance in Esperoct, turoctocog alfa pegol, works in the body in the same way as human factor VIII.
Maltese: Is-sustanza attiva f'Esperoct, turoctocog alfa pegol, taħdem fil-ġisem bl-istess mod bħall-fattur VIII uman.
English: Studies have found that Esperoct is effective at preventing and treating bleeding in patients with haemophilia A. Because Esperoct is ‘pegylated', patients on this medicine could also have fewer or less frequent injections than they would on conventional FVIII products.
Maltese: Peress li Esperoct huwa ‘pegilat', il-pazjenti fuq din il-mediċina jista' jirċievu wkoll inqas injezzjonijiet jew injezzjonijiet inqas frekwenti milli kieku jirċievu kieku jieħdu prodotti FVIII konvenzjonali.
English: Following treatment with factor VIII products, including Esperoct, some patients may develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Maltese: Wara kura bi prodotti tal-fattur VIII, inkluż Esperoct, xi pazjenti jistgħu jiżviluppaw inibituri (antikorpi) kontra l-fattur VIII, u dan jikkawża lill-mediċina li tieqaf taħdem u jirriżulta f'telf tal-kontroll talemorraġija.
English: However, part of the active substance in Esperoct (called PEG) may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment.
Maltese: Madankollu, parti mis-sustanza attiva f'Esperoct (imsejħa PEG) tista' takkumula fil-ġisem, inkluż fi struttura fil-moħħ imsejħa l-korojde pleksus, wara kura fit-tul.
English: As for all medicines, data on the use of Esperoct are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Esperoct hija ssorveljata kontinwament.
English: Esperoct must not be used in patients with allergy to hamster proteins.
Maltese: Esperoct ma għandux jintuża f'pazjenti b'allerġija għall-proteini talħemsters.
English: For the full list of side effects and restrictions with Esperoct, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Esperoct, ara l-fuljett ta' tagħrif.
English: Very rarely, patients may develop antibodies against hamster protein in the medicine and have allergic reactions.
Maltese: F'każijiet rari ħafna, il-pazjenti jistgħu jiżviluppaw antikorpi kontra l-proteina tal-ħemster fil-mediċina u jkollhom reazzjonijiet allerġiċi.
English: Part of the active substance is a chemical called polyethylene glycol (PEG), which is added to help the medicine remain in the body for longer and thereby prolong its action.
Maltese: Parti mis-sustanza attiva hija sustanza kimika msejħa polietilenglikol, (PEG), li hija miżjuda biex tgħin lill-mediċina tibqa' fil-ġisem għal aktar żmien u għaldaqstant ittawwal l-azzjoni tagħha.
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Maltese: Pazjenti b'emofilja A għandhom nuqqas ta' fattur VIII, proteina meħtieġa għall-koagulazzjoni normali tad-demm, u bħala riżultat jinfasdu faċilment.
English: What measures are being taken to ensure the safe and effective use of Esperoct?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Esperoct?
English: When bleeding episodes occurred, they were successfully treated with one or two further injections in 94% of cases.
Maltese: Meta seħħew l-episodji ta' emorraġija, dawn ġew ikkurati b'suċċess b'injezzjoni waħda jew tnejn oħra f'94 % tal-każijiet.
English: Esperoct is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by the lack of a clotting protein known as factor VIII.
Maltese: L-effetti sekondarji rrappurtati b'Esperoct huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: How is Esperoct used?
Maltese: Kif jintuża Esperoct?
English: Since this could potentially cause problems especially in children below 12 years of age, Esperoct is only approved for use in adults and children from 12 years of age.
Maltese: Minħabba li dan potenzjalment jista' jikkawża problemi speċjalment fi tfal taħt it-12-il sena, Esperoct huwa approvat biss għall-użu fl-adulti u fi tfal minn 12-il sena ‘il fuq.
English: MSD Polska Sp.z o.o.
Maltese: Polska MSD Polska Sp.z o.o.
English: What is vitamin D?
Maltese: X'inhi vitamina D?
English: *See sections 4.2 and 4.4
Maltese: *Ara sezzjonijiet 4.2 u 4.4
English: Common vertigo
Maltese: Komuni vertigo†
English: • Do not take with coffee or tea.
Maltese: • Tiħdux mal-kafe jew it-te.
English: • you suffer from kidney problems,
Maltese: • tbati minn problemi fil-kliewi,
English: 2 tablets 4 tablets 12 tablets
Maltese: 2 pilloli 4 pilloli 12-il pillola
English: 2 tablets 4 tablets 6 tablets 12 tablets
Maltese: 2 pilloli 4 pilloli 6 pilloli 12-il pillola
English: What is alendronate?
Maltese: X'inhu alendronate?
English: Date of first authorisation: 16 October 2009 Date of latest renewal: 18 September 2014
Maltese: Data tal-aħħar tiġdid: 18 ta' Settembru 2014.
English: Other medicines and VANTAVO
Maltese: Mediċini oħra u VANTAVO
English: - Inability to stand or sit upright for at least 30 minutes.
Maltese: - Nuqqas ta' kapacità li toqgħod bilwieqfa jew bilqieghda dritt għal tal-anqas 30 minuta.
English: • if you cannot stand or sit upright for at least 30 minutes,
Maltese: • jekk ma tistax toqgħod fuq saqajk jew toqgħod bilqieghda dritt għal talanqas 30 minuta,
English: 2031 BN, Haarlem, Netherlands
Maltese: 2031 BN, Haarlem, L-Olanda
English: Neopharmed Gentili S.p.A. Tel. + 39 02 89 13 21 regulatory@neogen.it
Maltese: Tel. + 39 02 89 13 21 regulatory@neogen.it
English: 2031 BN Haarlem The Netherlands
Maltese: 2031 BN Haarlem In-Netherlands
English: The other ingredients are microcrystalline cellulose (E460), lactose anhydrous (see section 2), medium chain triglycerides, gelatin, croscarmellose sodium, sucrose (see section 2), colloidal silicon dioxide, magnesium stearate (E572), butyl hydroxytoluene (E321), modified starch (maize), and sodium aluminium silicate (E554).
Maltese: Is-sustanzi l-oħra huma microcrystalline cellulose (E460), lactose anhydrous (ara sezzjoni 2), medium chain triglycerides, gelatin, croscarmellose sodium, sucrose (ara sezzjoni 2), colloidal silicon dioxide, magnesium stearate (E572), butyl hydroxytoluene (E321), modified starch (maize), u sodium aluminium silicate (E554).
English: Musculoskeletal pain
Maltese: Uġigħ muskoluskeletriku
English: What is osteoporosis?
Maltese: X'inhi l-osteoporożi?
English: Frequencies are defined as: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000)
Maltese: Il-frekwenzi huma ddefiniti bħala: komuni ħafna (≥1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1000 sa < 1/100), rari (≥ 1/10,00 sa, < 1/1000), rari ħafna (< 1/10,000)
English: The relevance to humans is unknown.
Maltese: Ir-relevanza għal bniedem għadu mhux magħruf.
English: The frequency of rare was estimated based on relevant clinical trials.
Maltese: Il-frekwenza ta' rari kienet stmata fuq bażi ta' provi kliniċi rilevanti.
English: VANTAVO 70 mg 2800 IU
Maltese: VANTAVO 70 mg 2800
English: Colecalciferol (vitamin D3)
Maltese: colecalciferol (vitamina
English: VANTAVO 70 mg 5600 IU
Maltese: VANTAVO 70 mg 5600
English: - Hypocalcaemia.
Maltese: - Ipokalċemija
English: Laboratory test findings
Maltese: Sejbiet minn testijiet tal-laboratorju
English: (malabsorption syndrome),
Maltese: assorbiment ħażin),
English: • cancer, chemotherapy, radiotherapy, corticosteroids, angiogenesis inhibitors, smoking
Maltese: • mard tal-kanċer, kimoterapija, radjuterapija, kortikosterojdi, inibituri tal-anġjoġenesi, tipjip
English: The mean increases from baseline in lumbar spine BMD at one year were 5.1 % (95 % CI: 4.8, 5.4 %) in the 70 mg once-weekly group and 5.4 % (95 % CI: 5.0, 5.8 %) in the 10 mg daily group.
Maltese: Iż-żjidiet medji mill-linja bażi ta' riferiment fis-sinsla lumbari fi żmien sena kienu 5.1 % (95 % CI: 4.8, 5.4 %) fil-grupp ta' 70 mg darba fil-ġimgħa u 5.4 % (95 % CI: 5.0, 5.8 %) fil-grupp ta' 10 mg kuljum.
English: VANTAVO 70 mg/2,800 IU tablets EU/1/09/572/001 - 2 tablets
Maltese: VANTAVO 70 mg/5600 IU pilloli EU/1/09/572/006 - 2 pilloli
English: - It is particularly important to understand the information in section 3 before taking this medicine.
Maltese: - Huwa importanti ħafna li tifhem l-informazzjoni f'sezzjoni 3 qabel tieħu din il-mediċina.
English: In this study alendronate daily reduced the incidence of  1 new vertebral fracture by 47 % (alendronate 7.9 % vs. placebo 15.0 %).
Maltese: F'dan l-istudju alendronate mogħti kuljum naqqas linċidenza ta'≥1 frattura vertebrali ġdida b' 47 % (alendronate 7.9 % kontra plaċebo 15.0
English: The percentage of patients with vitamin D deficiency was 0.3 % in the Vitamin D3 2,800 group vs. zero in the Vitamin D3 5,600 group.
Maltese: Il-perċentwal ta' pazjenti b'defiċjenza ta' vitamina kien 0.3 % fil-grupp tal-Vitamina D3 2,800 vs. żero fil-grupp tal-Vitamina D3 5600.
English: How can osteoporosis be treated?
Maltese: Kif tista' tiġi trattata l-osteoporożi?
English: EU/1/09/572/001 (2 tablets) EU/1/09/572/002 (4 tablets) EU/1/09/572/003 (6 tablets) EU/1/09/572/004 (12 tablets)
Maltese: EU/1/09/572/001 (2 pilloli) EU/1/09/572/002 (4 pilloli) EU/1/09/572/003 (6 pilloli) EU/1/09/572/004 (12-il pillola)
English: Do not take VANTAVO
Maltese: Tiħux VANTAVO
English: The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss medju, esklussivament mill-għadam, huwa tal-anqas 28 litru fil-bnedmin.
English: Excipients with known effect Each tablet contains 63 mg lactose (as lactose anhydrous) and 16 mg sucrose.
Maltese: Kull pillola fiha 63 mg lactose (bħala lactose anhydrous) u 16-il mg sucrose.
English: Excipients with known effect Each tablet contains 62 mg lactose (as lactose anhydrous) and 8 mg sucrose.
Maltese: Kull pillola fiha 62 mg lactose (bħala lactose anhydrous) u 8 mg sucrose.
English: 200 ml) , so that VANTAVO is adequately absorbed.
Maltese: 200 ml), sabiex VANTAVO jiġi assorbit kif suppost.
English: VANTAVO 70 mg/5,600 IU tablets
Maltese: VANTAVO 70 mg/5600 IU pilloli
English: When radioactive vitamin D3 was administered to healthy subjects, the mean urinary excretion of radioactivity after 48 hours was 2.4 %, and the mean faecal excretion of radioactivity after 4 days was 4.9 %.
Maltese: Meta ngħatat il-vitamina D3 radjuattiv lil suġġetti f'saħħithom, l-eliminazzjoni medja fl-awrina tarradjuattività wara 48 siegħa kienet ta' 2.4 %, u l-eliminazzjoni medja tar-radjuattività fl-ippurgar wara 4 ijiem kienet ta' 4.9 %.
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Bioavailability was decreased similarly to an estimated 0.46 % and 0.39 % when alendronate was administered one hour or half an hour before a standardised breakfast.
Maltese: Il-bijodisponibiltà kienet l-istess imnaqqsa għal stima ta' 0.46 % u 0.39 % meta alendronate kien mogħti siegħa jew nofs siegħa qabel kolazzjon standardizzat.
English: Patients in the Vitamin D3 2,800 group received VANTAVO (70 mg/2,800 IU) (n=299) and patients in the Vitamin D3 5,600 group received VANTAVO (70 mg/2,800 IU) plus an additional 2,800 IU vitamin D3 (n=309) once a week; additional vitamin D supplements were allowed.
Maltese: Il-pazjenti fil-grupp tal-Vitamina D3 2800 irċevew VANTAVO (70 mg/2800 IU) (n=299) u l-pazjenti fil-grupp tal-Vitamina D3 5600 irċevew VANTAVO (70 mg/2800 IU) flimkien ma' 2,800 IU addizzjonali ta' Vitamina D3 (n=309) darba filġimgħa; supplimenti ta' vitamina D addizzjonali kienu permessi.
English: Following a single 10 mg intravenous dose, the renal clearance of alendronate was 71 ml/min, and systemic clearance did not exceed 200 ml/min.
Maltese: Wara doża waħdanija minn ġol-vina ta' 10 mg, l-eliminazzjoni renali ta' alendronate kienet 71 ml/min, u leliminazzjoni sistemika ma qabżitx 200 ml/min.
English: The bioavailability of the 2800 IU vitamin D3 in VANTAVO is similar to 2800 IU vitamin D3 administered alone.
Maltese: Ilbijodisponibiltà tal-2800 IU vitamina D3 f'VANTAVO hija simili għal 2800
English: The alendronate component in the VANTAVO (70 mg/2800 IU) combination tablet and the VANTAVO (70 mg/5,600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Maltese: Il-komponent alendronate fil-pillola kombinata VANTAVO (70 mg/2800 IU) u fil-pillola kombinata VANTAVO (70 mg/5600 IU) huwa bijoekwivalenti għal pillola ta' 70 mg alendronate.
English: However, the incidences of decreases in serum calcium to < 8.0 mg/dl (2.0 mmol/l) and serum phosphate to  2.0 mg/dl (0.65 mmol/l) were similar in both treatment groups.
Maltese: Madankollu, l-inċidenzi ta' tnaqqis tal-kalċju fis-serum għal < 8.0 mg/dl (2.0 mmol/l) u l-fosfat fisserum għal ≤ 2.0 mg/dl (0.65 mmol/l) kienu simili fiż-żewġ gruppi ta' kura.
English: Alendronate sodium has been studied in a small number of patients with osteogenesis imperfecta under the age of 18 years.
Maltese: Alendronate sodium kien studjat f'numru żgħir ta' pazjenti taħt l-età ta' 18-il sena b'osteoġenesi imperfecta.
English: †, pruritus Uncommon rash, erythema Rare rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
Maltese: Rari raxx b'fotosensittività, reazzjonijiet severi talġilda li jinkludu s-sindrome ta' Stevens-Johnson u nekrolisi epidermika tossika‡
English: VANTAVO 70 mg/2800 IU tablets VANTAVO 70 mg/5,600 IU tablets
Maltese: VANTAVO 70 mg/2800 IU pilloli VANTAVO 70 mg/5600 IU pilloli
English: Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D. Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Maltese: Olestra, żjut minerali, orlistat, u sekwestranti tal-aċidi biljari (eż. cholestyramine, colestipol) jistgħu jimpedixxu l-assorbiment ta' vitamina D.
English: Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate (see section 4.5 and section 4.8).
Maltese: Xorb ieħor (li jinkludi l-ilma minerali), ikel u xi prodotti mediċinali oħrajn x'aktarx inaqqsu l-assorbiment ta' alendronate (ara sezzjoni 4.5 u sezzjoni 4.8).
English: Common abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation Uncommon nausea, vomiting, gastritis, oesophagitis*, oesophageal erosions*, melena
Maltese: Komuni uġigħ addominali, dispepsja, stitikezza, dijarea, gass, ulċera esofagali*, disfaġja*, distensjoni addominali, regurġitazzjoni tal-aċidu
English: Concentrations of alendronate in plasma following therapeutic oral doses are too low for analytical detection (< 5 ng/ml).
Maltese: Konċentrazzjonijiet ta' alendronate fil-plażma wara dożi terapewtiċi orali huma baxxi wisq għal osservanza analitika (< 5 ng/ml).
English: Vitamin D3 is produced in the skin by conversion of 7-dehydrocholesterol to vitamin D3 by ultraviolet light.
Maltese: Il-vitamina D3 hija magħmula fil-ġilda permezz tal-bidla ta' 7-dehydrocholesterol għal vitamina D3 bid-dawl ultravjola.
English: BLISTER FOR VANTAVO 70 mg/5,600 IU
Maltese: FOLJA GĦAL VANTAVO 70 mg/5600 IU
English: Hypocalcaemia must be corrected before initiating therapy with VANTAVO (see section 4.3).
Maltese: L-ipokalċemija għandha tiġi korretta qabel ma tinbeda t-terapija b'VANTAVO (ara sezzjoni 4.3).
English: • hair loss; itching,
Maltese: • dardir; rimettar,
English: Vitamin D3 is rapidly metabolized by hydroxylation in the liver to 25-hydroxyvitamin D3, and subsequently metabolized in the kidney to 1,25-dihydroxyvitamin D3, which represents the biologically active form.
Maltese: Il-vitamina D3 hija malajr metaboliżżata b'hydroxylation fil-fwied għal 25-hydroxyvitamin D3, u sussegwentament metaboliżżata fil-kilwa għal 1,25-dihydroxyvitamin D3, li tirrapreżenta l-forma bijoloġika attiva.
English: Rare hypersensitivity reactions including urticaria and angioedema
Maltese: Rari reazzjonijiet ta' sensittività eċċessiva fosthom urtikarja u anġjoedima
English: Early on, osteoporosis usually has no symptoms.
Maltese: Fl-istadju bikri, l-osteoporożi ġeneralment ma jkollhiex sintomi.
English: The following instructions should be followed exactly in order to minimise the risk of oesophageal irritation and related adverse reactions (see section 4.4):
Maltese: L-istruzzjonijiet li ġejjin għandhom jiġu segwiti bl-eżatt sabiex jitnaqqas ir-riskju ta' irritazzjoni talesofagu u reazzjonijiet avversi relatati (ara sezzjoni 4.4):
English: • you are undergoing chemotherapy or radiotherapy,
Maltese: • qed ikollok kemoterapija jew radjuterapija,
English: In post-marketing experience, these symptoms have rarely been severe and/or incapacitating (see section 4.8).
Maltese: F'esperjenzi ta' wara t-tqegħid fis-suq, dawn is-sintomi rarament kienu serji u/jew inkapaċitanti (ara sezzjoni 4.8).
English: Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose, intolleranza għal galactose, id-defiċjenza ta' Lapp lactase, jew l-assorbiment ħażin ta' glucose-galactose jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu din il-mediċina.
English: Rare oesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUBs (perforation, ulcers, bleeding)
Maltese: Rari tidjiq esofagali*, ulċerazzjoni orofarinġali*, PUBs (perforazzjoni, ulċeri, fsada) gastrointestinali fin-naħa ta' fuq§