FrancophonIA/ELRC3.0 huggingface dataset:
English: Missed dose
Maltese: Doża eċċessiva
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with ibandronic acid.While on treatment invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to ibandronic acid administration.
Maltese: Il-pazjenti kollha għandhom ikunu mħeġġa li jżommu iġjene orali tajba, ikollhom spezzjonijiet dentali regolari u minnufih jirrapportaw kwalunkwe sintomu orali bħal mobilità dentali, uġigħ jew nefħa, jew nuqqas ta' fejqan ta' selħiet jew rilaxx waqt il-kura b'ibandronic acid.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 mg/2 ml
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI 2 mg/2 ml
English: Based on the results of study BM 16550, ibandronic acid 3 mg intravenous injection, administered every 3 months is expected to be at least as effective in preventing fractures as the oral regimen of ibandronic acid 2.5 mg daily.
Maltese: Ibbażat fuq ir-riżultati tal-istudju BM 16550, ibandronic acid 3 mg injezzjoni ġol-vina darba kull 3 xhur huwa mistenni li tkun minn tal-inqas effettiva daqs ibandronic acid 2.5 mg kuljum biex tippreveni l-ksur.
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq is-siringa wara “EXP”.
English: Concentrate for solution for infusion 1 vial (6 mg/6 ml)
Maltese: Konċentrat għal soluzzjoni għall-infużjoni Kunjett 1 (2 mg/2 ml)
English: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis for the jaw, and ocular inflammation (see paragraph “description of selected adverse reactions” and section 4.4).
Maltese: L-aktar reazzjonijiet avversi serji rrappurtati huma reazzjoni anafilattika/xokk, ksur mhux tipiku talgħadma tal-wirk, osteonekrosi tax-xedaq, irritazzjoni gastrointestinali u infjammazzjoni fl-għajnejn, (ara l-paragrafu “Deskrizzjoni ta' reazzjonijiet avversi magħżula” u sezzjoni 4.4).
English: Other things that can increase the risk of fractures include:
Maltese: Affarijiet oħra li jistgħu jżidu r-riskju ta' ksur jinkludu:
English: ibandronic acid 3 mg injection every 3 months (N=334)
Maltese: Injezzjoni ta' ibandronic acid 3 mg kull 3 xhur (N=334)
English: The inhibition of endogenous bone resorption has also been documented by 45Ca kinetic studies and by the release of radioactive tetracycline previously incorporated into the skeleton.
Maltese: L-inibizzjoni ta' assorbiment endoġenu tal-għadam ġiet dokumentata wkoll permezz ta' studji kinetiċi ta' 45Ca u r-reħa ta'tetracycline radjuattiv li qabel kien inkorporat fl-iskeletru.
English: Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.
Maltese: Ibandronic acid Accord 3 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest bħal bisphosphonates oħra mogħtija ġol-vina, jista' jikkawża tnaqqis temporanju fil-valuri ta' kalċju fisserum.
English: * Note albumin-corrected serum calcium concentrations are calculated as follows: Albumin-corrected serum calcium (mmol/l)
Maltese: Kalċju fis-serum ikkoreġut għall-albumina (mmol/l)
English: Three-year lumbar spine BMD increase compared to placebo was 5.3 % and 6.5 % compared to baseline.
Maltese: Iż-żjieda fil-BMD tas-sinsla lumbari fuq tliet snin meta mqabbla mal-plaċebo kienet ta' 5.3% u 6.5% meta mqabbla mal-linja bażi.
English: The strong effect on vertebral fractures was furthermore reflected by a statistically significant reduction of height loss compared to placebo (p<0.0001).
Maltese: L-effett qawwi fuq il-ksur vertebrali kien rifless ukoll minn tnaqqis statistikament sinifikanti ta' telf fit-tul meta mqabbel mal-plaċebo (p<0.0001).
English: • flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints.
Maltese: • sintomi jixbħu lill-influwenza, inkluż deni, tregħid u tertir, sensazzjoni ta' skomdu, uġigħ fl għadam u muskoli u ġogi juġgħu.
English: 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: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Accord Healthcare S.L.U.
Maltese: Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq u l-Manifattur Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq Accord Healthcare S.L.U.
English: Trochanter BMD
Maltese: TAGĦRIF
English: Biochemical markers of bone turn-over
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: How to store Ibandronic acid Accord 6.
Maltese: Kif taħżen Ibandronic acid Accord 6.
English: Common (may affect up to 1 in 10 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100):
English: The proportion of patients who increased or maintained their BMD at one year at both lumbar spine and total hip was 76.2 % in the 3 mg injection every 3 months arm and 67.2 % in the 2.5 mg daily orally arm (p=0.007).
Maltese: Il-proporzjon ta' pazjenti li żiedu jew żammew il-BMD tagħhom wara sena kemm fis-sinsla lumbari kif ukoll fil-ġenbejn totali kien ta' 76.2 % fil-grupp ta' injezzjoni ta' 3 mg kull 3 xhur u 67.2 % filgrupp ta' 2.5 mg orali kuljum (p=0.007).
English: Ibandronic acid Accord 3 mg solutionfor injection (for osteoporosos indications) Medicinal product subject to medical prescription.
Maltese: Ibandronic acid Accord 3 mg soluzzjoni għal injezzjoni (għal indikazzjonijiet osteoporożi)
English: For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed (see section 5.2):
Maltese: Għall-pazjenti b'indeboliment moderat tal-kliewi (CLcr ≥ 30 u <50 ml/min) jew b'indeboliment sever tal-kliewi (CLcr <30 ml/min) li qed jiġu ttrattati għall-prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u mard metastatiku tal-għadam għandhom jiġu segwiti r-rakkomandazzjonijiet ta' dożaġġ li ġejjin (ara sezzjoni 5.2):
English: Cholelithiasis
Maltese: KUNJETT
English: Renal clearance of ibandronic acid in patients with various degrees of renal impairment is linearly related to creatinine clearance (CLcr).
Maltese: Espożizzjoni għal ibandronic acid f'pazjenti b'livelli varji ta' indeboliment tal-kliewi hija relatata mattneħħija tal-krejatinina (CLcr - creatinine clearance).
English: It is recommended that the product once diluted be used immediately (see point 5 of this leaflet ‘How to store Ibandronic Acid Accord').
Maltese: Huwa rrakkommandat li l-prodott la darba jkun dilwit jintuża immedjatament (ara l-punt 5 ta' dan ilfuljett ‘Kif taħżen Ibandronic acid Accord').
English: Elderly population (see section 4.2)
Maltese: Anzjani (ara sezzjoni 4.2)
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion ibandronic acid
Maltese: Ibandronic acid Accord 2 mg konċentrat sterili ibandronic acid
English: • if you have high or low levels of vitamin D, calcium or any other minerals.
Maltese: • jekk għandek livelli għoljin jew baxxi ta' vitamina D, kalċju jew ta' kwalunkwe minerali oħrajn.
English: Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Maltese: Il-fatturi tar-riskju possibbli għall-osteonekrosi tal-kanal estern tas-smigħ jinkludu użu ta' sterojdi u kimoterapija u/jew fatturi tar-riskju lokali bħal infezzjoni jew trawma.
English: Ibandronic acid Accord 6 mg concentrate for solution for infusion ibandronic acid
Maltese: Ibandronic acid Accord 6 mg konċentrat sterili ibandronic acid
English: In reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0.3 and 1 mg/kg/day and decreased fertility in males at 1 mg/kg/day and in females at 1.2 mg/kg/day.
Maltese: Fi studji dwar l-effett fuq is-sistema riproduttiva fuq il-firien b'għoti fil-vina, ibandronic acid naqqas l-għadd tal-isperma b'dożi ta' 0.3 u 1 mg/kg/jum u naqqas il-fertilità fl-irġiel b'1 mg/kg/jum u fin-nisa b'1.2 mg/kg/jum.
English: Patients should receive supplemental calcium and/or vitamin D if dietary intake is inadequate.
Maltese: Teħid xieraq ta' kalċju u vitamina D huwa importanti fil-pazjenti kollha.
English: General advice
Maltese: Parir ġenerali
English: Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50 - 60 % of total clearance, and is related to creatinine clearance.
Maltese: It-tneħħija mill-kliewi (madwar 60 ml/min f'nisa b'saħħithom wara l-menopawsa) tkopri 50 - 60% tat-tneħħija totali u hija relatata mat-tneħħija tal-krejatinina.
English: There is no evidence for any clinically relevant inter-ethnic differences between Asians and Caucasians in ibandronic acid disposition.
Maltese: Ma hemm l-ebda evidenza ta' xi differenza ta' relevanza klinika bejn ir-razez Ażjatiċi u Kawkasi fiddispożizzjoni ta' ibandronic acid.
English: Each ml of solution contains 1 mg ibandronic acid.
Maltese: • Kull ml ta' soluzzjoni fih 1 ml ibandronic acid.
English: Ibandronic acid injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients (see section 4.4 and section 5.2)
Maltese: Injezzjoni ta' Ibandronic acid mhix irrakkomandata għall-użu f'pazjenti li għandhom krejatinina fisserum 'l fuq minn 200 μmol/l (2.3 mg/dl) jew li għandhom tneħħija tal-krejatinina (mkejla jew stmata) taħt 30 ml/min minħabba tagħrif kliniku limitat disponibbli minn studji li jinkludu pazjenti bħal dawn (ara sezzjoni 4.4 u sezzjoni 5.2).
English: In this study, ibandronic acid was evaluated at oral doses of 2.5 mg daily and 20 mg intermittently as an exploratory regimen.
Maltese: F'dan l-istudju, ibandronic acid kien evalwat f'dożi orali ta' 2.5 mg kuljum u 20 mg b'mod intermittenti bħala kors epsloratorju.
English: No systemic accumulation was observed when ibandronic acid was administered intravenously once every 4 weeks for 48 weeks to patients with metastatic bone disease.
Maltese: L-ebda akkumulazzjoni sistematika ma ġiet osservata meta ibandronic acid ġie amministrat ġol-vina darba kull 4 ġimgħat għal 48 ġimgħa lillpazjenti b'mard metastatiku ta' l-għadam.
English: Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease , invasive dental procedures e.g. tooth extractions
Maltese: Iġjene batuta orali, mard perjodontali, dentaturi li ma joqogħdux sew, storja ta' mard tas-snien, proċeduri dentali invażivi eż. qlugħ tas-snien.
English: Furthermore, ibandronic acid 3 mg injection every 3 months was proven superior to oral ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p<0.001, and at two years, p<0.001.
Maltese: 7 % tal-pazjenti li kienu qed jirċievu 2.5 mg ta' terapija orali kellhom BMD tas-sinsla lumbari miżjud jew miżmum (p=0.001).
English: Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with ibandronic acid (see section 4.2).
Maltese: Madankollu, skont l-eżami kliniku tal-pazjent individwali, huwa rakkomandat li jsir monitoraġġ tal-funzjoni renali, tal-kalċju fis-serum, tal-fosfat u tal-manjesju f'pazjenti li jiġu trattati b'ibandronic acid (ara sezzjoni 4.2).
English: Patients with hepatic impairment (see section 4.2)
Maltese: Pazjenti b'indeboliment tal-fwied (ara sezzjoni 4.2)
English: If you have breast cancer that has spread to your bones, then the recommended dose is 6 mg every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
Maltese: Jekk għandek kanċer tas-sider li nfirex fl-għadam, id-doża rrakkomandata hija ta' 3 kunjetti (6 mg) kull 3-4 ġimgħat, bħala infużjoni fil-vini fuq medda ta' mill-inqas 15-il minuta.
English: In clinical trials, therapy has continued for up to 96 weeks.
Maltese: Fil-provi kliniċi, it-terapija baqgħet sejra sa 96 ġimgħa.
English: The treatment effect of ibandronic acid was further assessed in an analysis of the subpopulation of patients who, at baseline, had a lumbar spine BMD T-score below -2.5 (table 4).
Maltese: L-effett tal-kura ta' ibandronic acid kien evalwat ukoll f'analiżi tas-sottopopolazzjoni ta' pazjenti li fillinja bażi kellhom il-punteġġ T tal-BMD tas-sinsla lumbari taħt -2.5 (tabella 4).
English: Clinical studies in the prevention of skeletal events in patients with breast cancer and bone metastases
Maltese: Studji kliniċi fil-prevenzjoni ta' episodji skeletriċi fil-pazjenti bil-kanċer tas-sider u metastasi flgħadam
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodju (23 mg) f'kull kunjett, i.e. ‘essenzjalment bla sodju'.
English: In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg is an adequate single dose.
Maltese: Fil-parti l-kbira tal-pazjenti b'iperkalċimija severa (kalċju fis-serum ikkoreġut għallalbumina*>3 mmol/l jew 12 mg/dl) doża waħda ta' 4 mg hija adegwata.
English: No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or above 30 ml/min).
Maltese: L-ebda aġġustament fid-doża ma huwa meħtieġ għall-pazjenti b'indeboliment ħafif tal-kliewi (CLcr ≥50 u <80 ml/min).
English: Patients with known hypersensitivity to other bisphosphonates
Maltese: Pazjenti b'sensittività eċċessiva magħrufa għal bisphosphonates oħrajn.
English: As renal function decreases with age, this is the only factor that should be considered (see renal impairment section).
Maltese: Hekk kif il-funzjoni renali tonqos bl-eta', dan huwa l-uniku fattur li għandu jiġi kkunsidrat (ara sezzjoni indeboliment tal-kliewi).
English: • You should take calcium and vitamin-D supplements while receiving Ibandronic acid Accord.
Maltese: • Għandek tieħu supplimenti ta' kalċju u vitamina D waqt li qed tirċievi Ibandronic acid Accord.
English: Ibandronic acid Accord concentrate for solution for infusion should be administered as an intravenous infusion.Care must be taken not to administer Ibandronic acid Accord concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
Maltese: L-ebda evidenza ta' tossiċità diretta fuq il-fetu jew effetti teratoġeniċi ma ġew osservati għal ibandronic acid fil-firien u fil-fniek ittrattati ġol-vina.
English: An expected decrease in bone turnover, normal quality of bone and absence of defects in mineralization were also seen after two years of treatment with ibandronic acid 3 mg injection.
Maltese: Dehru ukoll tnaqqis mistenni fil-bidla tal-għadam, kwalità normali tal-għadam u nuqqas ta' difetti filmineralizzazjoni wara sentejn ta' kura b'injezzjoni ta' ibandronic acid 3 mg.
English: This regimen reduced the occurrence of new radiographic vertebral fractures by 62 % (p=0.0001) over the three year duration of the study.
Maltese: Matul it-tliet snin ta' studju, dan il-kors naqqas lokkorrenza ta' ksur vertebrali radjografiku ġdid b'62% (p=0.0001).
English: Dosage
Maltese: Sess
English: After 5 years of receiving Ibandronic acid Accord, please consult with your doctor whether you should continue to receive Ibandronic acid Accord.
Maltese: Wara li tkun ilek tirċievi Ibandronic acid Accord għal 5 snin, jekk jogħġbok ikkonsulta mat-tabib tiegħek dwar jekk għandekx tkompli tirċievi Ibandronic acid Accord.
English: Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe must not be mixed with calcium-containing solutions (such as Ringer-Lactate solution, calcium heparin) or other intravenously administered medicinal products.
Maltese: Ibandronic acid Accord 3 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest m'għandux jitħallat ma' soluzzjonijet li fihom il-kalċju (bħal soluzzjoni Ringer-Lactate, calcium heparin) jew prodotti mediċinali oħra li jingħataw ġol-vina.
English: Bone pain
Maltese: U LUŻU
English: In a study in 130 patients with metastatic breast cancer the safety of ibandronic acid infused over 1 hour or 15 minutes was compared.
Maltese: Fi studju f'130 pazjent b'kanċer metastatiku tas-sider, kienet imqabbla is-sigurtà ta' ibandronic acid mgħoti bħala infużjoni fuq medda ta' siegħa jew 15-il minuta.
English: NAME OF THE MEDICINAL PRODUCT Ibandronic acid Accord 2 mg concentrate for solution for infusion Ibandronic acid Accord 6 mg concentrate for solution for infusion
Maltese: Ibandronic acid Accord 2 mg konċentrat għal soluzzjoni għall-infużjoni Ibandronic acid Accord 6 mg konċentrat għal soluzzjoni għall-infużjoni
English: Total hip BMD 1.8 [1.5, 2.1]
Maltese: BMD 3.8 [3.4, 4.2] BMD totali tal-ġenbejn BMD tal-għonq tal-wirk 1.6
English: Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting ibandronic acid therapy for metastatic bone disease.
Maltese: Ipokalċimja u disturbi oħra tal-metaboliżmu tal-għadam u tal-minerali għandhom jiġu stmati u kkurati b'mod effettiv qabel tinbeda terapija ta' injezzjoni b'Ibandronic acid Accord.
English: The median time to relapse (return of albumin-corrected serum calcium to levels above 3 mmol/l) was 18-19 days for the 2 mg and 4 mg doses.
Maltese: Iż-żmien medju sa biex il-livell jerġa jogħla (ir-ritorn għal-livelli ta' 'l fuq minn 3 mmol/l ta' kalċju fis-serum ikkoreġut għall-albumina) kien ta' 18-19-il ġurnata b'dożi ta' 2 mg u 4 mg.
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion Each vial contains 2 ml of concentrate.
Maltese: Ibandronic acid Accord 2 mg konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 2 ml ta' konċentrat.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I : Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: Clinically meaningful reductions in serum CTX levels were observed at all time points measured.
Maltese: Tnaqqis ta' sinifikat kliniku fil-livelli fis-serum ta' CTX kienu osservati fil-punti kollha ta' ħin imkejjla.
English: Children and adolescents Ibandronic acid Accord must not be used in children or adolescents below 18 years.
Maltese: Tfal u adolexxenti Ibandronic acid Accord m'għandux jintuża fi tfal u adolexxenti b'età inqas minn 18-il sena.
English: The injection should be given into the vein by a physician or qualified/trained health care worker.
Maltese: L-injezzjoni għandha tingħata ġol-vina minn tabib jew ħaddiem ikkwalifikat/imħarreġ fil-qasam mediku.
English: Table 3 Secondary Efficacy Results (Breast cancer Patients with Metastatic Bone Disease)
Maltese: Tabella 3 Riżultati Sekondarji ta' l-Effikaċja (Pazjenti b'Kanċer tas-Sider b'MardMetastatiku tal-Għadam)
English: There are no data on the effects of ibandronic acid from humans.
Maltese: M'hemmx dejta dwar l-effetti ta' ibandronic acid fuq il-bniedem.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2° C to 8°C unless dilution has taken place in controlled and validated aseptic condition.
Maltese: Jekk ma tintużax immedjatament, il-perjodu u l-kundizzjonijiet tal-ħażna qabel l-użu huma r-responsabilità ta' min jużah u normalment ma jkunx ta' iktar minn 24 siegħa f'temperatura ta' bejn 2°C - 8°C, sakemm id-dilwizzjoni ma sseħħx f'kundizzjoni asettika kontrollata u vvalidata.
English: • mouth ulcers, swollen lips (‘“cheilitis”'), oral thrush
Maltese: • ulċeri fil-ħalq, xufftejn minfuħin (‘kelite'), infezzjoni mill-moffa ġol-ħalq
English: Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck
Maltese: Jekk ikollok wieħed mis-sintomi li ġejjin, bħal qtugħ ta' nifs/diffikultà biex tieħu nifs, griżmejn jinħassu mitbuqa, nefħa fl-ilsien, sturdament, sensazzjoni ta' telf ta' koxjenza, ħmura jew nefħa talwiċċ, raxx fil-ġisem, dardir u rimettar, għandek tavża lit-tabib jew l-infermier tiegħek minnufih (ara sezzjoni 4).
English: Virginia 22827
Maltese: Elkton Virginia 22827
English: adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.225 milligrams Al).
Maltese: 3adsorbit fuq amorphous aluminium hydroxyphosphate sulphate adjuvant (0.225 milligramma Al).
English: Cross-protective efficacy
Maltese: Effikaċja kross-protettiva
English: Persistence of Immune Response of Gardasil
Maltese: Persistenza ta' Rispons Immuni ta' Gardasil
English: Naïve to ≥ 1 HPV Type
Maltese: Naïve għal ≥ Tip ta' HPV 1
English: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Franza
English: Merck Sharp & Dohme Corp. Sumneytown Pike P.O.Box 4
Maltese: Merck Sharp & Dohme Corp. Sumneytown Pike
English: 1 dose (0.5 ml) contains: HPV Type 6 L1 protein 20 µg HPV Type 11 L1 protein 40 µg HPV Type 16 L1 protein 40 µg HPV Type 18 L1 protein 20 µg adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).
Maltese: L1 20 µg Proteina HPV Tip 11 L1 40 µg Proteina HPV Tip 16 L1 40 µg Proteina HPV Tip 18 L1 20 µg adsorbit fuq amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU- BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: 16- to 26-Year-Old Women (Protocols 013 and 015)
Maltese: Nisa bejn 16 u 26 sena (Protokolli 013 u 015)
English: HPV types 6 and 11 are responsible for approximately 90% of genital wart cases.
Maltese: HPV tipi 6 u 11 huma responsabbli għal madwar 90 % tal-każijiet ta' felul ġenitali.
English: {MM/YYYY}
Maltese: (wara JIS).
English: Sodium chloride, L-histidine, polysorbate 80, sodium borate, water for injections.
Maltese: Sodium chloride, L-histidine, polysorbate 80, sodium borate, u ilma għall-injezzjonijiet.
English: Merck Sharp & Dohme Corp. 2778 South East Side Highway Elkton
Maltese: L-Istati Uniti tal-Amerika Merck Sharp & Dohme Corp. 2778 South East Side Highway
English: Consequently, the frequency of these adverse events is qualified as "not known".
Maltese: Konsegwenza ta' dan, il-frekwenza ta' dawn il-każijiet avversi tikkwalifika bħala “mhux magħruf”.
English: In clinical studies, 57.5% of women aged 16 to 26 years and 31.2% of women aged 24 to 45 years who received Gardasil used hormonal contraceptives during the vaccination period.
Maltese: Fi studji kliniċi, 57.5 % tan-nisa ta' età bejn 16 u 26 sena u 31.2% tan-nisa ta' età bejn 24 sena u 45 sena li rċivew Gardasil użaw kontraċettivi ormonali matul il-perijodu ta' vaċċinazzjoni.
English: If you are from 9 to and including 13 years of age
Maltese: Individwi minn 9 snin sa u inkluż 13-il sena
English: % of seropositive subjects n % of seropositive subjects
Maltese: % ta' individwi seropożittivi
English: The term "premalignant genital lesions" in section 4.1 corresponds to high-grade cervical intraepithelial neoplasia (CIN 2/3), high-grade vulvar intraepithelial neoplasia (VIN 2/3) and highgrade vaginal intraepithelial neoplasia (VaIN 2/3).
Maltese: It-terminu "leżjonijiet ġenitali premalinni" f'sezzjoni 4.1 jikkorrespondi għal neoplasja intraepiteljali ċervikali ta' grad għoli (CIN 2/3), neoplasja intraepiteljali vulvari ta' grad għoli (VIN 2/3) u neoplasja intraepiteljali vaġinali ta' grad għoli (VaIN 2/3).
English: 1 dose vial, 0.5 ml.
Maltese: Doża waħda, 0.5 ml.